BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 3093300 · Received May 6, 2013

    Report

    Report Number
    6000034-2013-00833
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Date of Event
    May 25, 2010
    Report Date
    June 9, 2010
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERY WAS NOT WORKING. THE EQUIPMENT WAS REMOVED FROM SERVICE, AND A REPLACEMENT WAS SENT. NO REPORTS OF PATIENT INJURY ARE ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196394 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM, PRODUCT CODE: MCM MCM COCHLEAR LTD. CP800

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention